Actively Recruiting
The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer: a 1:1 Randomized Phase III Clinical Trial
Led by Fudan University · Updated on 2026-02-27
124
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the role of additional radiotherapy after surgery for patients with high-risk, locally advanced differentiated thyroid cancer. It is a phase III randomized controlled clinical trial comparing two treatment approaches to see which better prevents cancer recurrence in the lymph nodes and surrounding areas. The study focuses on patients who have had surgery but still have residual cancer tissue, assessing the impact of adding radiotherapy to standard radioiodine therapy (RAI). Participants are randomly assigned to one of two groups: the experimental group receives both radiotherapy and RAI, while the control group receives only RAI. Radiotherapy involves external radiation using advanced techniques such as intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) within six weeks after surgery. Both treatments are administered within six months after surgery. During the study, participants will be monitored for at least five years after surgery to measure outcomes including local-regional recurrence-free survival, recurrence rates, progression-free survival, overall survival, adverse effects, and quality of life. Researchers will conduct regular follow-ups to assess these outcomes and track participants’ health and treatment response over this period. The total participation duration extends through these long-term evaluations to gather comprehensive safety and effectiveness data.
CONDITIONS
Brief Title
Adjuvant Radiotherapy in High Risk Locally Advanced DTC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily agrees and signs informed consent
- Age 14 years or older and under 80 years, any gender
- Histopathological diagnosis of differentiated thyroid cancer
- Underwent total or near total thyroidectomy
- Surgery did not achieve complete tumor removal; residual tumor volume less than 2 cm3 if applicable
- Normal main organ functions
- Good compliance and cooperation with follow-up
You will not qualify if you...
- Previous radiation therapy to the head or neck area
- Differentiated thyroid cancer with poorly differentiated or undifferentiated components
- Presence of distant metastasis
- Previous 131I treatment
- Previous or current targeted therapy, immunotherapy, or chemotherapy
- Other active malignant tumors within 5 years or simultaneously, except certain cured local tumors
- Pregnant or lactating women
- Other physical illnesses affecting ability to receive standard treatment
- Serious illnesses or social/family factors affecting safety or data collection
- Claustrophobia preventing radiation therapy
- Deemed unsuitable by attending physicians for other reasons
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months after surgery
Participants receive either radiotherapy combined with radioiodine treatment or radioiodine treatment alone within 6 months after surgery.
Duration - Up to 5 years after surgery
Participants are monitored for outcomes including recurrence, survival, adverse events, and quality of life for up to 5 years after surgery.
Trial Site Locations
Total: 1 location
1
Fudan Univeristy Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
N
Naisi Huang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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